Medication info

Zatinol Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOralApproval withdrawn
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Aju Pharmaceutical Co., Ltd.
Appearance
Hard capsules with a yellow upper and lower part filled with white to off-white crystalline contents
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201804552 · Approved 2018.11.16

This product's status changed to Approval withdrawn on 2025.03.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric lesions in gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Take 300mg of nizatidine once daily at bedtime, or take 150mg orally twice daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, take 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; outcomes with longer-term use are unknown. 3. Gastroesophageal reflux disease Adults: Take 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Take 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment for patients with severe renal impairment Active duodenal ulcers, gastroesophageal reflux disease (GERD), benign gastric ulcers Creatinine clearance 20~50 ml/min: 150mg daily Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150mg every other day Creatinine clearance < 20 ml/min: 150mg every 3 days

Ingredients

Manufacturer
Aju Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric lesions in gastritis

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbation of chronic gastritis
View approved original text

This medication is used to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It also alleviates symptoms of erosive and ulcerative esophagitis diagnosed by endoscopy and heartburn caused by gastroesophageal reflux disease (GERD). It is effective in alleviating symptoms such as erosion, bleeding, erythema, and edema, which are gastric mucosal lesions that occur during acute exacerbations of acute and chronic gastritis. Therefore, this medication is used broadly for the treatment of various diseases and symptoms of the gastric and duodenal systems.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Take 300mg of nizatidine once daily at bedtime, or take 150mg orally twice daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, take 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; outcomes with longer-term use are unknown. 3. Gastroesophageal reflux disease Adults: Take 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Take 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment for patients with severe renal impairment Active duodenal ulcers, gastroesophageal reflux disease (GERD), benign gastric ulcers Creatinine clearance 20~50 ml/min: 150mg daily Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150mg every other day Creatinine clearance < 20 ml/min: 150mg every 3 days

Precautions

This medication is a type of H2-receptor antagonist used to reduce gastric acid secretion for the treatment of gastrointestinal diseases. Do not take this medication if you have experienced an allergic reaction to this drug or similar medications in the past. Patients with allergies to medications or with liver or kidney function problems should use this drug with particular caution. Patients with impaired kidney function may have elevated drug concentrations in the blood, so the dosage should be reduced or the administration interval increased as advised by a physician. If during treatment symptoms of hypersensitivity such as skin rash, itching, shortness of breath, or swelling of the face or neck occur, stop taking the medication immediately and consult a doctor. Blood disorders such as anemia or leukopenia may occur, so consult medical personnel if these symptoms are suspected. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, or nausea; notify medical staff if these become severe. As liver function may be affected, seek medical attention immediately if symptoms of hepatitis or jaundice arise. Mental confusion, headaches, drowsiness, and dizziness may occur rarely, so caution is advised when driving or operating machinery. Rapid heartbeat may occur, so inform your doctor of any abnormal symptoms. In rare cases, breast enlargement may occur in women, and decreased libido or erectile dysfunction has also been reported. Be alert for skin-related symptoms such as rash, excessive sweating, or hives. This medication is primarily excreted through the kidneys; therefore, elderly patients or patients with reduced kidney function should have kidney function tests done prior to administration and should be monitored regularly during treatment. Women who are pregnant or may become pregnant should carefully consider the effects of this medication on the fetus, and take it only when necessary. For breastfeeding women, this medication may be excreted in breast milk, so it should be taken only when absolutely necessary. Safety in children has not been established; use in children should be approached with caution. This drug has minimal interactions with other medications; however, caution should be exercised when used concurrently with high doses of aspirin, as serum salicylate levels may increase. In case of overdose, symptoms may include vomiting, diarrhea, and increased salivation, so adhere to the prescribed dosage and visit a medical facility immediately in case of excess intake. This medication may mask the symptoms of gastric cancer, so it should only be used after accurate diagnosis if gastric cancer is suspected. If therapeutic effects are not seen, other treatment methods should be considered, and it is important to regularly check liver and kidney function.

Side effects

  • rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
Show 29 more
  • diarrhea
  • dry mouth
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynecomastia
  • sweating
  • urticaria
  • exfoliative dermatitis
  • vasculitis
  • hyperuricemia
  • fever
  • chest pain
  • myalgia
  • rhinitis
  • pharyngitis
  • cough

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container that prevents light exposure, and at room temperature between 1 and 30 degrees Celsius. Storing it this way can maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Hard capsules with a yellow upper and lower part filled with white to off-white crystalline contents

Package unit

30 capsules/bottle, 300 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.